Childhood ObesityNCT03885518

Painted Playgrounds: Aim 2: Assessments

A study testing Playground Stencils in people with Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Childhood Obesity
What is being tested?: Playground Stencils
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2018to 30 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A child who attends a childcare center enrolled to Aim 1.
A child who is ≥ 3 years and ≤ 6 years old
Your child will continue to attend this same childcare center for the duration of the study.

Who cannot join

Parent/legal guardian is unwilling to provide written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 2: Assessments

The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling intervention aimed at increasing physical activity and improving fundamental motor skill functioning of preschool aged children. 72 children from local licensed childcare centers will participate in individual assessments at baseline and follow-up 6-8 weeks later. Assessments include height/weight, surveys and wearing a physical activity monitor (accelerometer) for 7 days. A parent/legal guardian will provide consent for their child to participate and will also complete a brief survey about their child's lifestyle and habits.

Conditions: Childhood Obesity
Being tested: Playground Stencils
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Playground StencilsOther
The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.

Study groups in NCT03885518
Study group	Role	What they receive
Intervention	Active comparator	Participants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks Receives: Other: Playground Stencils
Wait-List	Placebo comparator	Participants attending the childcare centers randomized to this arm will receive the stencil activities approximately 8 weeks after enrolling, after baseline and follow-up assessments have been completed. Receives: Other: Playground Stencils

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Moderate to Vigorous Activity (MVPA) During Recess
To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to increase physical activity, change in MVPA during recess will be measured using accelerometers. The main outcome variable will be percentage of recess time spent in MVPA, measured objectively using a physical activity monitor (i.e. accelerometer).
Measured: Baseline and follow-up (6 to 8 weeks after playground stenciling)
Change in Fundamental Motor Skill Development
The Test of Gross Motor Development, 3rd edition (TGMD-3) was utilized to assess fundamental motor skills. The test consists of a total of 13 skills which are designed to assess locomotor (6 skills) and ball (7 skills). Children complete two trials, and if they meet the specified performance criteria, they are scored a 1. If they fail to meet the criteria, they are scored a zero. Trials 1 and 2 are added to get the raw scores of locomotor and ball skill. For locomotor, this range is from 0-46; for ball skills, children can score from 0-54. Raw scores are then converted to scaled scores based on the TGMD-3 age and gender charts. The scaled scores are added to determine a total scaled score. The total scaled score has a percentile ranking to determine what percentile the child is in (<1,>99). The post-TGMD-3 total percentile was subtracted for the change score from the baseline percentile. A positive value indicates an improvement in fundamental motor skills, where
Measured: Baseline and follow-up (6 to 8 weeks after playground stenciling)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 201830 Jun 2019

First posted21 Mar 2019
Study start15 Dec 2018
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Childhood ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03885518
Sponsor's protocol ID: PBRC 2017-040
Status last verified: Nov 2024
First submitted: 29 Jan 2019
Last updated: 24 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Webster EK, Kepper MM, Saha S, Beyl RA, Kracht CL, Romain JS, Staiano AE. Painted playgrounds for preschoolers' physical activity and fundamental motor skill improvement: a randomized controlled pilot trial of effectiveness. BMC Pediatr. 2023 Sep 9;23(1):455. doi: 10.1186/s12887-023-04260-2.
PubMed 37689622

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 2: Assessments
ClinicalTrials.gov ID: NCT03885518
Acronym / sponsor ID: PBRC 2017-040
Conditions: Childhood Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Blue Cross Blue Shield
Study start: 15 Dec 2018 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 21 Mar 2019 (actual)
Results: Posted 24 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Intervention	Active comparator	Other: Playground StencilsParticipants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks
Wait-List	Placebo comparator	Other: Playground StencilsParticipants attending the childcare centers randomized to this arm will receive the stencil activities approximately 8 weeks after enrolling, after baseline and follow-up assessments have been completed.

Who may qualify

Ages: 3 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

A child who attends a childcare center enrolled to Aim 1.
A child who is ≥ 3 years and ≤ 6 years old
Your child will continue to attend this same childcare center for the duration of the study.

Key exclusion criteria (1 listed)

Parent/legal guardian is unwilling to provide written informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Playground StencilsThe stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.	Other	Intervention, Wait-List

Primary outcome

Change in Moderate to Vigorous Activity (MVPA) During Recess
Time frame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to increase physical activity, change in MVPA during recess will be measured using accelerometers. The main outcome variable will be percentage of recess time spent in MVPA, measured objectively using a physical activity monitor (i.e. accelerometer).
Change in Fundamental Motor Skill Development
Time frame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
The Test of Gross Motor Development, 3rd edition (TGMD-3) was utilized to assess fundamental motor skills. The test consists of a total of 13 skills which are designed to assess locomotor (6 skills) and ball (7 skills). Children complete two trials, and if they meet the specified performance criteria, they are scored a 1. If they fail to meet the criteria, they are scored a zero. Trials 1 and 2 are added to get the raw scores of locomotor and ball skill. For locomotor, this range is from 0-46; for ball skills, children can score from 0-54. Raw scores are then converted to scaled scores based on the TGMD-3 age and gender charts. The scaled scores are added to determine a total scaled score. The total scaled score has a percentile ranking to determine what percentile the child is in (<1,>99). The post-TGMD-3 total percentile was subtracted for the change score from the baseline percentile. A positive value indicates an improvement in fundamental motor skills, where

Results and safety

Results posted to the registry on 24 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	32	22
Control Group	19	17

Primary outcome: Change in Moderate to Vigorous Activity (MVPA) During Recess

Time frame: Baseline and follow-up (6 to 8 weeks after playground stenciling). Mean (Standard Deviation). Unit: percentage of time

Measure	Intervention n = 32	Control n = 19
Value	1.4 (3.7)	6.2 (4.1)

Primary outcome: Change in Fundamental Motor Skill Development

Time frame: Baseline and follow-up (6 to 8 weeks after playground stenciling). Mean (Standard Deviation). Unit: percentile

Measure	Intervention n = 32	Control n = 19
Baseline	21.2 (3.7)	25.8 (4.8)
Follow-up	37.7 (4.4)	34.1 (6.1)

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Control	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): Limitations include the small sample for this pilot study. Only four schools were examined in one region of the United States, so results may only be generalizable to this area or to programs with similar characteristics. The limited access to concrete space in most ECE centers is a limitation that must be considered for the expansion of this intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37689622Webster EK, Kepper MM, Saha S, Beyl RA, Kracht CL, Romain JS, Staiano AE. Painted playgrounds for preschoolers' physical activity and fundamental motor skill improvement: a randomized controlled pilot trial of effectiveness. BMC Pediatr. 2023 Sep 9;23(1):455. doi: 10.1186/s12887-023-04260-2.

Related trials for Childhood Obesity

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
RecruitingPhase 3
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maura Kepper, PhD principal investigator

Pennington Biomedical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Playground Stencils in people with Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Moderate to Vigorous Activity (MVPA) During Recess (time frame: Baseline and follow-up (6 to 8 weeks after playground stenciling)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03885518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.